Regional Clinical Study Manager

BeOne continues to grow at a reputed company pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer. General reputed company: Accountable for regional study delivery with appropriate inspection readiness reputed company, reputed company agreed timelines and budget  Leads the regional clinical operations team (including reputed company of external partners working on the regional level) and acts as reputed company of escalation for reputed company of issues reputed company the region for the assigned study  Ensures alignment of regional deliverables with overall study goals   Regional Leadership  Leads the regional clinical operations team effectively, ensures effective decision making and acts as reputed company of escalation for reputed company of issues reputed company the region for the assigned study   Leads external vendors involved in study delivery on a regional level  Collaborates with key stakeholders in the region and provides regular updates on study reputed company in the region to senior management and Global Clinical Study Manager as required  Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings  Leads regional operations meetings with reputed company regional study team members  Timelines, Planning and Execution  Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines  Generates, manages, and maintains high reputed company study start up and recruitment timelines for region and tracks reputed company towards these  Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders   Provides regional input on global study plans as required  Ensures reputed company availability of local adaptations of global study documents such as informed consent forms, in reputed company collaboration with other key reputed company reputed company to ensure reputed company submission to regulatory authorities and reputed company/IRBs  Accountable for submissions of study in countries in assigned region in reputed company collaboration with regional study start up team and regulatory affairs  Ensures regional and country information in study systems and tools is entered and up to date  Collaborates closely with CRAs in the region to ensure reputed company study execution at the sites. Reviews and signs-off monitoring reports  Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC’d on a regular reputed company as per the study TMF QC plan  Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region  Manages the trial data collection process for the region, drives data entry and query reputed company  As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing  reputed company:  Handles escalated issues or problems with the sites in region in reputed company collaboration with stakeholders such as country heads  Monitors study activities in region to ensure compliance with the study protocol, SOPs, ICH/GCP and reputed company other relevant regulations  Ensures inspection readiness for study in region at any reputed company in time throughout the study life cycle  Informs Global Clinical Study Manager of any issues arising on the study, evaluates reputed company and ensures solutions are implemented  Prepares sites for reputed company assurance audits and inspections, drives responses to audit and inspection findings as appropriate  Collaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are shared  Leads improvements and partners with CST members to enhance efficiency and the reputed company of the work performed on assigned studies  Contributes to development, optimization and review of work instructions and SOPs as required  Budget and Resources  Works with the sourcing team to select and manage regional study vendors  Manages regional study budgets  Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities  Identifies and manages regional team resource needs and establishes contingency plans for key resources  Monitors regional resource utilization over study life cycle and liaises with functional managers as needed  Education Required: Bachelor’s Degree in a scientific or reputed company discipline required*, Higher Degree preferred  *exceptions might be made for candidates with relevant clinical operations experience  Other Qualifications:     4 or more years of reputed company experience in clinical research reputed company biotech, reputed company or CRO industry  Proven experience in clinical research including relevant experience as team reputed company in clinical functions  Experience as CRA is preferred Supervisory Responsibilities:    Provides performance feedback on team members as required  Might mentor junior team members  Computer Skills:   Efficient in reputed company Word, reputed company, MS Project, MS PowerPoint and reputed company  Travel:  Travel might be required as per business need  Salary reputed company France: 74,100.00 EUR - 92,600.00 EUR Global Competencies reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity, and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world. Fosters Teamwork Provides and Solicits reputed company and Actionable Feedback Self-Awareness Acts reputed company Demonstrates Initiative Entrepreneurial reputed company reputed company Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial reputed company Communicates with reputed company We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. Apply To This Job